K945242 is an FDA 510(k) clearance for the NERVE MONITOR ELECTRODES/STIMULATOR PROBES. This device is classified as a Stimulator, Nerve (Class II - Special Controls, product code ETN).
Submitted by Micromed Development Corp. (Clearwater, US). The FDA issued a Cleared decision on December 27, 1994, 61 days after receiving the submission on October 27, 1994.
This device falls under the Ear, Nose, Throat FDA review panel. Regulated under 21 CFR 874.1820.
| 510(k) Number | K945242 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 27, 1994 |
| Decision Date | December 27, 1994 |
| Days to Decision | 61 days |
| Submission Type | Traditional |
| Review Panel | Ear, Nose, Throat (EN) |
| Summary | Summary PDF |
| Product Code | ETN — Stimulator, Nerve |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 874.1820 |